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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

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Auditors Hit EMA for Failing to Meet Conflict of Interest Standards

Posted 12 October 2012 | By

Auditors with the European Court of Auditors (ECA) have determined that the European Medicines Agency (EMA), despite its attempts to increase transparency and implement conflict-of-interest (COI) policies, is falling short of its responsibilities to, "Adequately manage COI situations."

"A number of shortcomings of varying degrees have been identified in Agency-specific policies and procedures as well as their implementation," ECA wrote.

"After examining the situation at these agencies, we have drawn up a list of general and specific recommendations which, if properly implemented, might bring significant improvements in the management of COI situations not only in the selected Agencies but in all EU Institutions and decentralised bodies," said&nbsp;Igors Ludboržs, the ECA member responsible for the report.

Auditors said EMA had a number of policies that it should immediately-if it has not already-implement, including candidate screening policies, COI management plans, defining COIs across project areas, improved transparency, COI training policies and enforcement mechanisms.

ECA also said the agency needs to better address, "Post-employment issues in coordination with all the appointing bodies involved," a possible reference to former EMA Executive Director Thomas L&ouml;nngren, who controversially formed a consulting firm before even leaving office.

EMA Responds

EMA, meanwhile, said it &nbsp;believed it had, "Some of the most advanced policies and procedures for declaring, assessing and managing potential conflicts of interests in place."

ECA's remarks, however, were hedged in relation to the COI policies of other agencies with established problems with COI. EMA did have some of the most advanced policies, ECA said, but only, "Out of the selected agencies." The three other agencies investigated by ECA were the European Food Safety Agency (EFSA), European Aviation Safety Agency (EASA) and the European Chemicals Agency (ECHA).

ECA began its report midway through 2011, EMA noted, and its findings did not adequately capture some of the changes made at EMA, which has moved aggressively since appointing Guido Rasi, executive director of EMA, to implement such policies.

While contending that these policies were sufficient to blunt many of the report's recommendations, EMA said it would still assess its policies for ways to improve.

"We will look carefully at the recommendations of the Court, together with the European Commission, the other EU agencies and our national counterparts in the European medicines network," &nbsp;Rasi said in a statement.

In an interview, Ludboržs said the ECA intends to follow up with EMA and the other agencies in a few years to ensure they have raised their standards to meet ECA's COI requirements.